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U.S. Department of Health and Human Services

Class 2 Device Recall KING LTS D, Size 5, 100027, Oropharyngeal Airway

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  Class 2 Device Recall KING LTS D, Size 5, 100027, Oropharyngeal Airway see related information
Date Initiated by Firm December 15, 2009
Date Posted January 27, 2011
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-0979-2011
Recall Event ID 54350
510(K)Number K021634  K033186  
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.

Intended use: Airway management by providing a patent airway to allow patient ventilation.
Code Information all product produced prior to 12/2009.
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060
For Additional Information Contact Tony Barbour
317-776-6823
Manufacturer Reason
for Recall		 King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat
FDA Determined
Cause 2		 Labeling False and Misleading
Action On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.
Quantity in Commerce 25,000 all products
Distribution Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAE and Original Applicant = KING SYSTEMS CORP.
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